Immunogenicity Lead - Large Molecule Bioanalysis

Requisition Number: 5742

Position Title: Immunogenicity Lead, Large Molecule Bioanalysis

External Description:

Who we are 
Worldwide Clinical Trials is a global, midsize CRO that pushes boundaries, innovates, and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. 

Large Molecule Bioanalysis is an integrated function with responsibilities of assay development, assay validation, and sample analysis for supporting both preclinical and clinical studies. We collaborate with EP and LP clinical units, utilize deep science, and apply state-of-the-art platforms/technologies to offer high quality one package scientific service.

What you will do 
SUMMARY: We are seeking an experienced and highly motivated immunogenicity assay expert to join the Bioanalytical Team in Austin TX. The successful candidate will lead a team in developing and validating ADA assays as well as analyzing preclinical and clinical samples. As needed, this individual provides mentoring and oversight to the Scientific Support staff of the team.

• Manage immunogenicity assay team performing method development, validation, and sample testing.
• Develop, optimize, and troubleshoot immunogenicity assays using various platforms
• Lead immunogenicity team to design assay and troubleshoot on various large molecule modalities (e.g., mAb, ADC, fusion protein, bispecific…)
• Prepare or provide a scientific review of bioanalytical data and methods, protocols, and reports
• Work closely with functional leads to ensure that methods are effectively implemented and coordinate/complete method set-ups to ensure timelines are met
• Understand and apply GLP guidelines in all aspects of work and ensure staff compliance with SOP’s, safety, and other guidelines.  
• Manage, monitor, and support employees regarding performance, training, and goals
• Interface with clients, when necessary, and participate in sponsor audits. 

What you will bring to the role 

• Strong scientific and compliance support to immunogenicity programs
• Ability to direct and train others in laboratory skills and project-specific tasks related to their assigned studies.
• Must be able to work well with a variety of laboratory personnel and leadership.
• Excellent attention to detail, strong written and oral communication skills

Your experience 

• Demonstrated experiences and capabilities in developing and validating ADA assays
• GLP experience is a must
• Previous CRO experience is a plus
• Hamilton/Tecan automation experience is a plus

City:

State:

Employment Type: Regular

Community / Marketing Title: Immunogenicity Lead - Large Molecule Bioanalysis

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Austin, Texas US

CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.